FDA Device recall Z-1010-2014
INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting with codes 0022530
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting with codes 0022530 by Zimmer, citing zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was deter….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1010-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-11 |
| Published | 2014-02-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
Product
INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting with codes 0022530
Reason
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.
Identifiers
| code_info | 60625043 60678699 60690742 60728338 60747676 60757045 60813551 60864020 60864021 60915935 60915936 61003973…60625043 60678699 60690742 60728338 60747676 60757045 60813551 60864020 60864021 60915935 60915936 61003973 60806395 60829584 60864023 60867711 60867767 60550320 60569951 60597681 60653347 60690746 60735651 60757047 60757048 60808005 60817585 60829586 60829587 60864037 60864038 60864040 60867771 61161394 61190864 61194691 61215177 61319429 61379510 60518291 60606752 60620346 60711145 60728343 60757050 60806397 60806398 60829592 60829594 60867782 60867785 61071422 61150075 61173568 61319435 61319436 61379514 60748952 60762088 60806399 60876899 60876901 60876902 61248174 61325065 60123303 60130220 60135214 60142918 60150073 60218846 60243102 60279663 60309141 60323311 60338439 60349093 60387528 60393392 60407659 60422612 60422615 60422617 60422618 60505967 60505968 60569960 60597683 60597684 60602462 60620369 60620371 60690750 60690751 60714161 60714162 60735662 60735663 60757051 60757052 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1010-2014%22
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